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Recall Observatory FDA recall evidence

Device product

Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.

Z-0311-2018

July 14, 2017

Class II

Product summary

Firm
Philips Electronics North America Corporation
Event
Event 78833
Status
Terminated
Classification
Class II
Quantity
412
Official record key
device-enforcement:Z-0311-2018

Official wording

Reason: If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.

Code information: 9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.

Distribution pattern: 412 units affected.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.